The process for applying for D-class medical device registration with the Saudi Food and Drug Authority (SFDA) involves several key steps to ensure compliance with the regulatory requirements. Here's a detailed breakdown of the steps involved:

1. Determine Device Classification

• Step: Verify that your device qualifies as a D-class (low-risk) medical device. D-class devices generally include non-invasive products with minimal risks to patients or users, such as basic diagnostic tools or non-implantable items.
• Action: Review the SFDA’s medical device classification guidelines and match your device’s features and intended use to the categories outlined. D-class devices generally do not require clinical trials but must demonstrate safety and effectiveness through documentation.

2. Appoint a Local Authorized Representative (LAR)

• Step: If the manufacturer is located outside Saudi Arabia, they must appoint a Local Authorized Representative (LAR) in Saudi Arabia to manage the registration process.
• Action: The LAR will be responsible for submitting the application, maintaining communication with the SFDA, and handling post-market obligations such as adverse event reporting.

3. Gather the Required Documentation

The following documents are essential for D-class medical device registration with the SFDA:

• Device Description: A comprehensive description of the device, including its intended use, classification, and any specific features that differentiate it from similar products.
• Manufacturer Details: Include the name, address, and contact details of the manufacturer, as well as any relevant certifications (e.g., ISO 13485 for the quality management system).
• Risk Management Documentation: Provide a risk management report based on ISO 14971, which demonstrates how potential risks associated with the device have been identified, evaluated, and mitigated.
• Quality Management System (QMS) Certification: Submit the ISO 13485 certification (or equivalent) that verifies compliance with international standards for manufacturing medical devices.
• Clinical Data (if applicable): For most D-class devices, clinical data is not required, but if necessary (e.g., if the device has specific claims or is a novel product), submit appropriate clinical evidence.
• Labeling and Packaging: Include all labeling materials, such as the Instructions for Use (IFU) and the device packaging, ensuring they comply with SFDA requirements (e.g., Arabic and English labeling).
• Free Sale Certificate: If applicable, provide a certificate from the country of origin indicating that the device is legally marketed there.
• Declaration of Conformity: A document from the manufacturer confirming that the device complies with the relevant regulatory standards.

4. Register the Device Through the SDRS (Saudi Drug Registration System)

• Step: The registration application must be submitted via the Saudi Drug Registration System (SDRS), which is the SFDA’s online platform for medical device applications.
• Action:
  • Create or log into your account on the e-Services portal.
  • Select medical device registration and provide the necessary details about the device and manufacturer.
  • Upload the required documents and submit them for review.
• Fees: Ensure that you pay the relevant registration fees as determined by the SFDA. The fee amount depends on the device classification and other factors.

5. SFDA Review Process

• Step: After submitting the application, the SFDA will begin the technical review process.
• Action: During this phase, the SFDA will:
  • Assess the device safety, efficacy, and quality based on the provided documentation.
  • Verify the completeness of the application.
  • Review device labeling for compliance with SFDA requirements, including the use of Arabic and English.
  • Evaluate the risk management plan (ISO 14971 compliance) and the quality management system.
  • If needed, the SFDA may request additional information or clarification.

Duration: The review process typically takes 3-4 weeks, but it can vary depending on the device's complexity and the completeness of the application.

6. SFDA Decision

• Step: After completing the review, the SFDA will make a decision on the registration.
• Action:
  • Approval: If the device meets all SFDA requirements, the SFDA will approve the device and issue a registration certificate. The certificate will include the registration number, device classification, and expiration date.
  • Request for Additional Information: If the SFDA identifies issues or requires clarification, they will request further documentation or revisions. The applicant will have to submit the requested information for review.
  • Rejection: If the device fails to meet SFDA standards, the application may be rejected, and the applicant may need to address the deficiencies before resubmitting.

7. Issuance of Registration Certificate

• Step: If the device is approved, the SFDA will issue a registration certificate, officially allowing the device to be marketed and sold in Saudi Arabia.
• Action: The manufacturer or authorized representative will receive the registration certificate, which is valid for one year and must be renewed annually.

8. Post-Market Surveillance (PMS)

• Step: After the device is on the market, the manufacturer and Local Authorized Representative (LAR) must comply with SFDA post-market surveillance requirements.
• Action: This includes monitoring the device for adverse events or safety issues, conducting recalls if necessary, and submitting periodic safety reports to the SFDA. The manufacturer is also required to ensure that the device continues to meet the quality standards set by the SFDA.

9. Annual Registration Renewal

• Step: The device registration must be renewed annually to maintain its legal status in Saudi Arabia.
• Action: To renew, submit updated documentation, pay the renewal fees, and confirm compliance with all SFDA regulations. The renewal process ensures that the device remains compliant and up-to-date with any regulatory changes.